Medical foods take on the mass market

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Medical foods are clearly defined by FDA—or are they? Several companies have taken medical foods beyond the physician's office, while others are still unsure how to achieve the medical foods label.

Traditionally, medical foods were prescribed under the supervision of healthcare practitioners. Now, medical foods can be found in grocery stores and at pharmacy counters. Should they be? The definition of medical foods seems to be openly interpreted as the category grows.

The U.S. Food and Drug Administration (FDA) defines a medical food in three parts:

"a food which is formulated to be consumed or administered enterally under the supervision of a physician

and which is intended for the specific dietary management of a disease or condition

for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

The first bullet point has become muddied now that medical foods are increasingly available direct to consumers. Take Abbott Laboratories' Pedialyte, for example, regarded as one of the first retail medical foods. Abbott also owns Ensure, a mix of prebiotics and antioxidants to help support adult digestive tract health. The company captured a large portion of the U.S. medical foods market in 2009: $1 billion of the total $1.6 billion market estimated in the published paper, "History of Tube Feeding."

Medical foods isn't just big business—they have been found to provide life-changing relief for serious medical conditions. A recently published study in the Journal of Clinical Lipidology found that Metagenics' UltraMeal PLUS 360 combined with a low-glycemic, Mediterranean-style diet resulted in a 44 percent reduction or net resolution of metabolic syndrome over a 12-week period.

"All our medical foods are sold to licensed healthcare practitioners who dispense them," said Robert Lerman, M.D., Ph.D., director of Medicine and Extramural Clinical Research for Metagenics. "Exactly why the FDA has allowed these other so-called medical foods to be sold in this way isn't clear to me."

Some of Metagenics' products can be found at online retailers, but this isn't sanctioned by the company and a full-time staffer works to shut down these online sales. "This is not the way Metagenics intends to sell its products," said Lerman. Currently, more than 75,000 healthcare providers worldwide using Metagenics' science-based medical foods, nutritional formulas and lifestyle therapy programs.

"How someone purchases the product I do not think matters," said Douglas Kalman, Ph.D., RD, FACN. Kalman is director of business development for Miami Research Associates. "Ensure is considered medical food and is easily purchased in the nutritional aisles of the supermarket and not in the pharmacy section."

Discuss this Article 1

This is a great story because medical foods inhabit a curious gray area in that growing convergence between supplements, foods, and drugs. Omega-3 fish oil is a fine example because it can be all 4 depending on the marketing, not to mention dosage levels.